3Shape

GUDID 05902768365023

The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of the topographical characteristics of teeth from dental

3shape A/S

Dental CAD/CAM system, laboratory
Primary Device ID05902768365023
NIH Device Record Key2a17f022-1cde-4972-9671-48ce07036378
Commercial Distribution Discontinuation2018-02-15
Commercial Distribution StatusNot in Commercial Distribution
Brand Name3Shape
Version Model NumberD800
Company DUNS306826012
Company Name3shape A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com
Phone+4570272620
Emailsupport@3shape.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 15 Degrees Celsius and 35 Degrees Celsius
Storage Environment Atmospheric PressureBetween 7000 KiloPascal and 11000 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105902768365023 [Primary]

FDA Product Code

NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-21

On-Brand Devices [3Shape ]

05902768365313The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365221The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365214The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365207The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365191The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365184The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365177The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365160The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365153The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365146The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365122The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365085The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365078The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365047The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365030The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365023The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365016The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t
05902768365009The 3Shape dental scanner is an optical CAD/CAM device intended to obtain 3D digital images of t

Trademark Results [3Shape]

Mark Image

Registration | Serial
Company
Trademark
Application Date
3SHAPE
3SHAPE
79380982 not registered Live/Pending
3Shape A/S
2023-08-28
3SHAPE
3SHAPE
79175283 5130811 Live/Registered
3Shape A/S
2015-08-31
3SHAPE
3SHAPE
79122920 4565880 Live/Registered
3Shape A/S
2012-10-15
3SHAPE
3SHAPE
79068481 3790384 Live/Registered
3Shape A/S
2008-10-10

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